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Endoscopic sleeve gastroplasty (ESG) have emerged as an effective primary endoscopic therapy for weight loss. While ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus and therefore does not lead to decrease in fasting plasma ghrelin after procedure.
Recently, a new endoscopic technique involving the ablation of the gastric fundus has been developed, showing promising results with a reduction in fasting plasma ghrelin levels and a mean total body weight loss of 7.7%. Combining endoscopic gastric fundus mucosal ablation with ESG could potentially enhance the weight loss effects of ESG while maintaining an acceptable safety profile.
This pilot study aims to evaluate the efficacy, safety, and physiological effects of combining endoscopic sleeve gastroplasty with fundal mucosal ablation (ESG-FUMA) in obese patients eligible for endoscopic bariatric therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic sleeve gastroplasty with fundal mucosal ablation | Experimental | First part of procedure - endoscopic gastric fundus mucosal ablation Second part of procedure - endoscopic sleeve gastroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic sleeve gastroplasty with fundal mucosal ablation | Procedure | Mucosal ablation around the gastric fundus is initially performed using a hybrid argon plasma coagulation (H-APC) probe, following a submucosal saline injection, until ablation coagulum is visible. Subsequently, endoscopic sleeve gastroplasty (ESG) is performed using a full-thickness endoscopic suturing device (Overstitch, Apollo). This is done in a standard manner, employing 6-8 permanent full-thickness sutures along the greater curvature of the stomach in a running plication, starting from the angular incisura and extending proximally while sparing the fundus. Hemostasis is carefully checked and confirmed before the procedure is completed. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Weight change compared to baseline | baseline, 1,3,6,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) | within 30 days of procedure |
| Technical success rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen Ng | Contact | (852)35052956 | stephenng@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Ng, FRCSEd(Gen) | Prince of Wales Hospital, the Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese University of Hong Kong | Recruiting | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
successful completion of endoscopic procedures
| 1 day |
| Serum ghrelin levels | Serum ghrelin levels compared to baseline | baseline, 3,6,12 months |
| Blood pressure | Blood pressure and anti-hypertensive medication use compared to baseline | baseline, 1,3,6,12 months |
| Lipid profile | Lipid profile compared to baseline | baseline, 3,6,12 months |
| Pain scale after procedure | measured by visual analogue scale (0:no pain - 10:worst pain) | 3 days |
| Change in Quality of Life | measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) | baseline, 3,6,12 months |
| Gastric emptying symptoms | measured by gastroparesis cardinal symptom index (GCSI) - (0:best - 45:worst) | baseline, 3,6,12 months |
| Eating behaviors | measured by Three-Factor Eating Questionnaire (TFEQ-R21) - (21:worst - 84:best) | baseline, 3,6,12 months |
| Fasting glucose level | levels compared to baseline | baseline, 3,6,12 months |
| Insulin level | levels compared to baseline | baseline, 3,6,12 months |
| HbA1c level | levels compared to baseline | baseline, 3,6,12 months |
| hepatic steatosis index | level compared to baseline | baseline, 3,6,12 months |
| NAFLD fibrosis | NAFLD fibrosis scores compared to baseline (F0: no liver fibrosis - F4: significant liver fibrosis) | baseline, 3,6,12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |